We read with interest the comment of R. Dal-Ré on the CORIMUNO-19 trials design [1–5]. The key argument is that the cohort multiple randomised controlled trial (cmRCT) design implies an alteration of the informed process that can only be justified if three requirements are fulfilled: the research has important social value, it poses no more than minimal risks to participants, and it would be impracticable to carry out without consent process modification [6]. R. Dal-Ré acknowledges that the first two requirements were fulfilled for CORIMUNO-19 trials, but argues that, given the huge number of patients hospitalised with severe or critical coronavirus disease 2019 (COVID-19) in March 2020, trials would have been feasible without consent modification.

我们感兴趣地阅读了 R. Dal-Ré 对 CORIMUNO-19 试验设计的评论 [1-5]。关键论点是，队列多项随机对照试验 (cmRCT) 设计意味着对知情过程的改变，只有满足三个要求才能证明这一点：研究具有重要的社会价值，对参与者的风险不超过最低限度，并且在未经同意的情况下修改流程是不切实际的 [6]。R. Dal-Ré 承认 CORIMUNO-19 试验的前两项要求已得到满足，但他认为，鉴于 2020 年 3 月有大量患者因严重或危急的 2019 年冠状病毒病 (COVID-19) 住院，本应进行试验未经同意修改是可行的。